MAUDE Adverse Event Report: MEDTRONIC, INC. / HEARTWARE, INC. MEDTRONIC LVAD; VENTRICULAR (ASSIST) BYPASS

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2019

Event Type  malfunction  

Event Description

It was reported that lvad device sent.No history or active vad alarms related to this issue.Medtronic engineers engaged by clinical rep.Multiple conversations yesterday and today resulting in no action needed for this blood in the driveline.However medtronic would like us to contact them if he has an alarm.This fluid could trigger a possible "driveline fault" which could leak into the controller from the lvad line and the pump could stop.Md's all engaged and action plan created in case this occurs.No plan from medtronic for engineers to come and clean / dam the driveline since there is no protocol for these new drivelines.Surgeon re-assessed today and plan is for driveline exchange in the next few days.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC LVAD
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): MEDTRONIC, INC. / HEARTWARE, INC.
• MDR Report Key: 9156652
• MDR Text Key: 161493594
• Report Number: MW5090227
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1